Cancer Pain Clinical Trial
Official title:
Oncological Perineal Massage in Vaginal Stenosis and Dyspareunia in Women With Gynecological Cancer
The high incidence of gynecological cancers, together with dyspareunia and vaginal stenosis, some of its most frequent sequelae, create the need to continue studying and researching oncological physiotherapy techniques that treat and prevent these sequelae, in order to preserve and/or improve the quality of life of cancer patients. Therefore, through this study, we sought to verify the effectiveness of oncological perineal massage to treat pain during sexual intercourse and vaginal stenosis. The objective of this study will be to demonstrate the effectiveness of a treatment that will consist of a health education session related to the pelvic floor and the consequences related to cancer along with ten sessions of oncological perineal massage that will be carried out for fifty minutes, once a week.
Status | Recruiting |
Enrollment | 86 |
Est. completion date | December 3, 2024 |
Est. primary completion date | September 3, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 52 Years |
Eligibility | Inclusion Criteria: - Women between 18 and 52 years old - Oncology patients with a diagnosis of dyspareunia and vaginal stenosis related to treatments. - Patients with QT/RT/BT treatment who have a diagnosis of dyspareunia and vaginal stenosis. - Patients on hormonal suppressive treatment with a diagnosis of dyspareunia and vaginal stenosis. Exclusion Criteria: - Patients who do not accept intracavitary treatment. - Patients with abdominopelvic surgical treatment prior to oncological process. - Patients with a diagnosis of dyspareunia prior to cancer. - Patients with vaginal narrowing prior to cancer. - Patients with menopause at the time of cancer diagnosis |
Country | Name | City | State |
---|---|---|---|
Spain | Asociación Española Contra el Cáncer en la provincia de Santa cruz de Tenerife. | Santa cruz de Tenerife. | Tenerife |
Lead Sponsor | Collaborator |
---|---|
University of Alcala |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain (Visual Analoge Scale) | Visual Analogical Scale (VAS) is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients with similar conditions. VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured orientated from the left "0" (worst) to the right "10"(best) | Change from baseline at six months | |
Secondary | Criteria for Adverse Events (CTCAE) | Grade refers to the severity of the Adverse Events. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE based on a general guideline where grade 1 and grade 5 are the best and worst result respectively. | Change from baseline at six months | |
Secondary | Quality of life (EORCT QLQ-C30) | The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in all cancer patients. The scores obtained can have values between 0 and 100, which determines the level of impact of the cancer on the patient of each of the scales. High values on the global health and function status scales indicate a better quality of life, while on the symptoms scale it would indicate a decrease in quality of life since it indicates the presence of symptoms associated with cancer. | Change from baseline at six months | |
Secondary | Female sexual function index | Female sexual function index (FSFI) is a survey measuring the sexual functioning of women in six different domains: desire, arousal, lubrication, orgasm, satisfaction and pain.The items are then scaled to achieve a maximum score of 36. | Change from baseline at six months | |
Secondary | Likert questionnaire by sexual dysfunction | Likert scales are a structured way for researchers to gather diverse opinions and attitudes. They allow respondents to express agreement, disagreement, or neutrality concerning statements or questions. The scale values range from 1 to 5, with 1 being the worst result and 5 being the best result. | Change from baseline at six months |
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